We recently wrote that Physio-Control, Inc., a division of Medtronic, Inc., recalled its LifePak CR Plus Automated External Defibrillators (AED). The Food & Drug Administration (FDA) deemed that recall a Class I, the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of these products will cause serious injury or death. Physio-control makes external defibrillators.

Just prior, Medronic issued a recall of some of its portable Lifepak Automated External Heart Defibrillators because the button that activates the device is inaccessible, also an FDA-deemed Class I recall. More Medtronic Unit to Resume Sales of Lifepak Defibrillators

Recently, the U.S. Food and Drug Administration (FDA) hosted a meeting to look into the Medical Device Approval program, known as the 510(k), which quickens U.S. approval of some medical devices. Reuters previously wrote that this program could be facing changes. Pre-market notification, or the 510(k) process, is used to review and clear certain medical devices marketed in the U.S. The FDA receives more than
 3,000 510(k) submissions annually.

Now, says the FDA, is confronted with challenges when reviewing specific medical devices saying that expanded regulations might be called for, said Reuters. The agency said the accelerated processes make it difficult to review new products, especially when comparing new products to approved products. Industry had no issue with the current accelerated review process, which was expected. More More Medical Device Regulations Needed, FDA Staff Says

The Medical Device Approval program, known as the 510(k), which quickens US approvals of some medical devices, might be experiencing a change, says Reuters. Tomorrow, a meeting at the U.S. Food and Drug Administration (FDA) will be looking at the program.

Many consider the program controversial and moving beyond its original intent, which has led to problems with approved medical devices, noted Reuters. Tomorrow’s meeting will discuss key challenges related to pre-market notification, or the 510(k) process, used to review and clear certain medical devices marketed in the US. The FDA receives more than
3,000 510(k) submissions annually. More FDA to Discuss Changes to 510(k) Medical Device Approvals

Last week, we wrote that the U.S. Food and Drug Administration (FDA) unveiled an initiative to reduce unnecessary radiation exposure from medical imaging, specifically procedures with high radiation doses: Computed tomography (CT), nuclear medicine studies, and fluoroscopy. Considered among the greatest contributors to total radiation exposure within the U.S. population, these procedures use much higher radiation doses than other radiographic procedures, such as standard and dental X-rays and mammography. Now, an emerging tool will likely standardize protocols for CT scans when conducted on children, said Science Daily.

According to a new study in the Canadian Medical Association Journal (CMAJ), the tool is targeted to children with minor head injuries and will also help to reduce the number of CT scans performed, said Science Daily. Figures indicate that over 650,000 children with such injuries resulting in a loss of consciousness, amnesia, disorientation, and /or vomiting, are seen in hospitals nationwide every year, wrote Science Daily. Although critical as a diagnostic tool, especially for serious brain injuries, the procedures can expose children to the potentially adverse effects of ionizing radiation, ultimately increasing health care costs, explained Science Daily. More New CT Scan Standards Proposed for Kids with Minor Head Injury

Health Canada just announced that neXus I, II, and III Rollators have been recalled due to a variety of potential health and safety risks. Dana Douglas Inc. initiated the voluntary recall of certain rollators, which may break during use and could result in the user falling and suffering serious injury including bruising, broken bones, or death.

neXus 1 Model #4520, neXus 2 Model #4515, neXus 3 Model #4500, and neXus 3 Model #4500T rollators are included in this recall bearing specific serial numbers, which can be found on the inside rear leg of rollators. Specific serial numbers are listed in detail in the Health Canada release: More Nexus Rollators Recalled Over Fall Risk

Boston Scientific Corp.’s Cognis and Teligen brand defibrillators have a design flaw that can cause them to deliver unneeded, painful, and life-threatening shocks, according to an article in the journal HeartRhythm. The Wall Street Journal is reporting that the article’s authors say the Cognis and Teligen defibrillator defect could affect any of the more than 90,000 devices implanted in patients right now.

In December, Boston Scientific reported that the part connecting the defibrillator’s case to the leads to the heart had come loose on defibrillators implanted under the chest muscles of two patients. However, the company said in January that the problem had been fixed on defibrillators in production. Boston Scientific also said the problem was limited only to those patients who had a Cognis or Teligen defibrillator implanted under their chest muscles, rather than those who had it under the skin. About 5 percent of patients receiving the devices have had them implanted under chest muscles. More Researchers Say Boston Scientific Defibrillators Pose Dangers

Acacia Inc. is recalling IV Extension Sets with BD Q-Syte Luer Access Device. As we reported yesterday, the BD Q-Syte Luer Access Device was recalled by Becton Dickinson & Co. because of a defect that could cause an air embolism or leakage of blood or IV therapy, which may result in serious injury or death.

The Becton Dickinson recall involved 2.8 million BD Q-Syte Luer Access Device, as well as 2.9 million BD Nexiva units containing 5 million BD Q-Syte devices that were distributed in the United States, Asia, Canada, Europe, Mexico, the Middle East, South Africa and South America. Becton Dickinson & Co. is investigating reports of one death and one serious injury that may be linked to the recalled devices. Product failures occurred on lots of BD Q-Syte and BD Nexiva units distributed from November 2008 through November 2009, Becton Dickinson said. More Acacia Inc. Recalls IV Extension Sets with BD Q-Syte Luer Access Device

Becton Dickinson & Co. is recalling millions of BD Q-Syte Luer Access Devices and BD Nexiva Closed IV Catheter Systems. The recall was issued after determining that use of the devices could cause an air embolism or leakage of blood or IV therapy, which could lead to serious injury or death.

The recall was initiated on Oct. 28, 2009 after the company received complaints of problems due to air entry through a part of the device. Becton Dickinson & Co. is investigating reports of one death and one serious injury that may be linked to the problem. More Millions of Potentially Lethal IV Devices Recalled by Becton Dickinson

A statement I-Flow released last month regarding the safety of its pain pump was misleading, according to plaintiffs attorneys representing pain pump shoulder injury patients. The statement said I-Flow’s pain pump was cleared by clinical studies that did not include shoulder joint studies. But attorneys representing victims of alleged I-Flow pain pump shoulder injuries say the statement failed to reveal that I-Flow repeatedly sought approval for the pain pump without any studies verifying its safety for the specific use of orthopedic surgeries involving shoulder joints.

Commonly called intra-articular pain pumps, device like the one made by I-Flow are used after surgeries to deliver local anesthetics to a specific area through a plastic tube. Such pain pumps became popular with orthopedic surgeons in the late 1990s because they were seen as an alternative to extended hospital stays and safer than prescribing narcotic painkillers. However, they were never actually approved by the Food & Drug Administration (FDA) for use in joint surgery. More I-Flow Pain Pump Under Scrutiny, Blamed for Shoulder Injuries

Thomas Medical Products (TMP) formally announced a worldwide voluntary recall of the SafeSheath® CSG® Sheath Introducer the U.S. Food and Drug Administration (FDA), just announced. The defect involves reported fragmentation and embolization of the radiopaque (RO) soft tip during use due to material degradation.

The SafeSheath® CSG® Coronary Sinus Guide Hemostatic Introducer System with Infusion Sideport recall is a Class I. Class I recalls are the FDA’s most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death. More Class I Recall for SafeSheath Device